PTS_X BALLOON _Rev
Presentational Presentational

Sizing

PTS®/PTS-X™

PTS®/PTS-X™ Sizing balloon catheters are designed for use in patients with cardiovascular defects where accurate measurement of the defect is important to select the appropriately sized occluder device.  The X-line inner braided catheter tubing provides an extra high inner lumen strength and improved pushability.

Largest Selection of Sizing Balloon Options Available

The PTS®/PTS-X™sizing balloons are available in over 60 size configurations.  Balloon diameters range from 10.0-40.0mm and lengths from 1.0-6.0cm and are available on 80cm and 110cm usable catheter lengths.    

The PTS® sizing balloon is super-thin for a low deflated profile that maintains tip flexibility.  The double tapered balloon has short tapers at the distal and proximal ends for enhanced transition across the stenosis and post dilatation ease of withdrawal into the introducer.  Platinum image bands facilitate reliable positioning of the balloon for accurately sizing the defect. 

The catheter body is Polymeric, DEHP-free, and not made of natural rubber latex.  The balloon is a thermoplastic elastomer; non-compliant - which will not exceed +/- 10% of the labeled balloon size at RBP, is DEHP-free, and not made of natural rubber latex.

PTS®: Specifications, Instructions for Use, and Forms

Balloon Diameters (mm):  20.0-40.0
Balloon Lengths (cm):  3.0-5.0
Rated Burst Pressure (ATM): 0.5-1.5
Introducer Size (FR):  8-9
Indication:  Recommended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

PTS® IFUs:
US: IFU-360B
CANADA: RM0344-19M
INTERNATIONAL: RM0344-19M

Post Market Surveillance Form

PTS-X™: Specifications, Instructions for Use, and Forms

Balloon Diameters (mm):  10.0-40.0
Balloon Lengths (cm):  1.0-6.0
Rated Burst Pressure (ATM): 0.5-2.5
Introducer Size (FR):  6-9
Indication:  Recommended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

PTS-X™ IFUs:
US: IFU-360XB
CANADA: RM0344-27N
INTERNATIONAL: RM0344-27N

Post Market Surveillance Form

Balloon Diameter (mm) Balloon Length (cm) Introducer (FR) Shaft Size (FR) Usable Length (cm) Guide Wire (inches) Rated Burst Pressure (ATM) Maximum Volume (cc) Catalog Number Product
10.0 1.00 6 6.0 80 0.035 2.5 PTSX101 PTS-X
10.0 1.00 6 6.0 110 0.035 2.5 PTSX104 PTS-X
10.0 2.00 6 6.0 80 0.035 2.5 PTSX102 PTS-X
10.0 2.00 6 6.0 110 0.035 2.5 PTSX105 PTS-X
10.0 3.00 6 6.0 80 0.035 2.5 PTSX103 PTS-X
10.0 3.00 6 6.0 110 0.035 2.5 PTSX106 PTS-X
12.0 2.00 6 6.0 80 0.035 2.0 PTSX122 PTS-X
12.0 2.00 6 6.0 110 0.035 2.0 PTSX124 PTS-X
12.0 3.00 6 6.0 80 0.035 2.0 PTSX123 PTS-X
12.0 3.00 6 6.0 110 0.035 2.0 PTSX125 PTS-X
15.0 2.00 6 6.0 80 0.035 2.0 PTSX152 PTS-X
15.0 2.00 6 6.0 110 0.035 2.0 PTSX155 PTS-X
15.0 3.00 6 6.0 80 0.035 2.0 PTSX153 PTS-X
15.0 3.00 6 6.0 110 0.035 2.0 PTSX156 PTS-X
15.0 4.00 6 6.0 80 0.035 2.0 PTSX154 PTS-X
15.0 4.00 6 6.0 110 0.035 2.0 PTSX157 PTS-X
20.0 3.00 8 8.0 80 0.035 1.5 PTS203 PTS
20.0 3.00 8 8.0 80 0.035 1.5 PTSX203 PTS-X
20.0 3.00 8 8.0 110 0.035 1.5 PTS204 PTS
20.0 3.00 8 8.0 110 0.035 1.5 PTSX205 PTS-X
20.0 4.00 8 8.0 80 0.035 1.5 PTSX204 PTS-X
20.0 4.00 8 8.0 110 0.035 1.5 PTSX206 PTS-X
25.0 3.00 8 8.0 80 0.035 1.5 PTS253 PTS
25.0 3.00 8 8.0 80 0.035 1.5 PTSX253 PTS-X
25.0 3.00 8 8.0 110 0.035 1.5 PTS254 PTS
25.0 3.00 8 8.0 110 0.035 1.5 PTSX255 PTS-X
25.0 4.00 8 8.0 80 0.035 1.5 PTSX254 PTS-X
25.0 4.00 8 8.0 110 0.035 1.5 PTSX256 PTS-X
30.0 3.00 8 8.0 80 0.035 1.0 PTSX303 PTS-X
30.0 3.00 8 8.0 80 0.035 1.0 PTS303 PTS
30.0 3.00 8 8.0 110 0.035 1.0 PTS306 PTS
30.0 3.00 8 8.0 110 0.035 1.0 PTSX306 PTS-X
30.0 4.00 8 8.0 80 0.035 1.0 PTSX304 PTS-X
30.0 4.00 8 8.0 80 0.035 1.0 PTS304 PTS
30.0 4.00 8 8.0 110 0.035 1.0 PTS307 PTS
30.0 4.00 8 8.0 110 0.035 1.0 PTSX307 PTS-X
30.0 5.00 8 8.0 80 0.035 1.0 PTSX305 PTS-X
30.0 5.00 8 8.0 80 0.035 1.0 PTS305 PTS
30.0 5.00 8 8.0 110 0.035 1.0 PTSX308 PTS-X
30.0 5.00 8 8.0 110 0.035 1.0 PTS308 PTS
35.0 3.00 9 8.0 80 0.035 1.0 PTSX353 PTS-X
35.0 3.00 9 8.0 110 0.035 1.0 PTSX357 PTS-X
35.0 4.00 9 8.0 80 0.035 1.0 PTSX354 PTS-X
35.0 4.00 9 8.0 110 0.035 1.0 PTSX358 PTS-X
35.0 5.00 9 8.0 80 0.035 1.0 PTSX355 PTS-X
35.0 5.00 9 8.0 110 0.035 1.0 PTSX359 PTS-X
35.0 6.00 9 8.0 80 0.035 1.0 PTSX356 PTS-X
35.0 6.00 9 8.0 110 0.035 1.0 PTSX360 PTS-X
40.0 3.00 9 8.0 80 0.035 0.5 PTSX403 PTS-X
40.0 3.00 9 8.0 80 0.035 0.5 PTS403 PTS

Disclaimer

All products are subject to individual country regulations in regards to the importation and/or sale of these products. Refer to Instructions for Use for a complete listing of indications, contraindications, warnings, and precautions.

 

NuMED for Children

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34786 USA
Tel: 407-352-5200

 

NuMED Inc.

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Hopkinton, NY
12965 USA
Tel: 315-328-4491

 

NuMED Canada

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Cornwall, Ontario
K6J1G3 CANADA
Tel: 613-936-2592